Canadian clinical trial registry

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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

86 results found

Title
Status

 

ONC201 - ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

Open

ONC201 - ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

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DiagnosisGliomaStudy StatusOpen
PhaseIII
AgeN/ARandomisationYES
Line of treatmentFirst line treatment
Routes of Treatment AdministrationONC201 and placebo medication are capsules, taken by mouth
Last Posted Update2024-04-16
ClinicalTrials.gov #NCT05580562
International Sponsor
Chimerix
Principal Investigators for Canadian Sites
London Health Sciences Centre - Dr. Seth Climans (Adult only)
Children's Hospital Eastern Ontario (CHEO) - Dr. Donna Johnston
Sunnybrook Health Sciences Centre - Dr. Mary Jane Lim Fat
Princess Margaret Hospital - Dr. Julie Bennett
Centres
Medical contact
Dr. Donna Johnston
Dr. Lesleigh Abbott
Dr. Doaa Abdel Fattah
 
Social worker/patient navigator contact
Sherley Telisma
 
Clinical research contact
Carol Duchenne
 
Medical contact
Dr. Alexandra Zorzi
Dr. Shayna Zelcer
 
Social worker/patient navigator contact
Cindy Milne Wren
Jessica Mackenzie Harris
 
Clinical research contact
Mariam Mikhail
Medical contact
N/A
Social worker/patient navigator contact
N/A
Clinical research contact
N/A
Medical contact
N/A
Social worker/patient navigator contact
N/A
Clinical research contact
N/A

 

 

Study Description

This is a phase 3 study for patients with newly diagnosed diffuse glioma. To be eligible for this study, the participant's cancer must have a mutation called H3 K27M. This study explores whether adding treatment with the experimental drug called ONC201 after radiotherapy is effective in patients with this type of cancer. 

Inclusion Criteria
  • Able to understand the study procedures and agree to participate in the study by providing written informed consent and assent when applicable.
  • Body weight ≥ 10 kg
  • A new diagnosis of diffuse glioma with a H3 K27M mutation 
  • Received frontline radiotherapy (radiation) within 2-6 weeks of starting this study
  • Patient must be capable of self-care but may be unable to engage in normal activities or perform active work

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.

PEPN2121 - A Phase 1/2 Study of Tiragolumab (NSC# 827799) and Atezolizumab (NSC# 783608) in Patients With Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors

Open

PEPN2121 - A Phase 1/2 Study of Tiragolumab (NSC# 827799) and Atezolizumab (NSC# 783608) in Patients With Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors

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DiagnosisRecurrent/Refractory Atypical Teratoid/Rhabdoid Tumor, Kidney Medullary Carcinoma, Malignant Solid Neoplasm, Poorly Differentiated ChordomaStudy StatusOpen
PhaseI/II
Age12 Months and olderRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationAtezolizumab and tiragolumab are given intravenously (IV) as infusions
Last Posted Update2024-04-15
ClinicalTrials.gov #NCT05286801
International Sponsor
National Cancer Institute (NCI)
Principal Investigators for Canadian Sites
CHU Ste Justine - Dr. Monia Marzouki
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This is a phase I/II trial that studies how well the treatments tiragolumab and atezolizumab work when given to children with tumours that have either come back (relapsed) or did not respond to therapy (refractory). These tumours must have a certain mutation, meaning the cancer cells are missing important genes called SMARCB1 and SMARCA4. Tiragolumab and atezolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Inclusion Criteria
  • Participants must be between 1-18 years old for part A of this study. There is no upper age limit for part B
  • Participants must have one of the following cancers, that has either come back (relapsed) or did not respond to previous treatment (refractory):
    • Renal medullary carcinoma
    • Malignant rhabdoid tumor (extra-CNS)
    • Atypical teratoid rhabdoid tumor (CNS)
    • Poorly differentiated chordoma
    • Epithelioid sarcoma
  • Cancer must have the eligible mutation (SMARCB1 or SMARCA4)
  • Participants must be up and about for at least half their waking hours
  • Participants must meet all bloodwork criteria outlined for this study

Other inclusion and exclusion criteria may apply and will be discussed with you by your clinical team

PBTC-058 - Phase 2 Study of Intraventricular Omburtamab-based Radioimmunotherapy for Pediatric Patients With Recurrent Medulloblastoma and Ependymoma

Open

PBTC-058 - Phase 2 Study of Intraventricular Omburtamab-based Radioimmunotherapy for Pediatric Patients With Recurrent Medulloblastoma and Ependymoma

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DiagnosisRecurrent Medulloblastoma Recurrent EpendymomaStudy StatusOpen
PhaseII
Ageup to 21 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Irinotecan (IV) Drug: Temozolomide (Oral) Drug: Bevacizumab (IV) Drug: Omburtamab I-131 (via Intraventricular Access Device) Pre-medication: Drug: Liothyronine (Orally, NG, or G-tube) Drug: SSKI (Orally, NG, or G-tube) Drug: Dexamethasone (Oral) Drug: Antipyretic (Oral acetaminophen [15 mg/kg, 650 mg maximum] or equivalent) Drug: Antihistamine (IV diphenhydramine [1 mg/kg, 50 mg maximum] or equivalent) Drug: Anti-emetics (IV ondansetron [0.25 mg/kg, 16 mg maximum] or equivalent)
Last Posted Update2024-04-10
ClinicalTrials.gov #NCT04743661
International Sponsor
Sponsor:
Pediatric Brain Tumor Consortium

Collaborators:
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Y-mAbs Therapeutics, Inc
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Vijay Ramaswamy
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

 

For patients who have medulloblastoma or ependymoma, there is a clear need to develop more effective therapies. This research will study an investigational drug called 131I-omburtamab, which is given in an intraventricular access device, to see if it is safe for children when added to standard chemotherapy (anti-cancer therapy). The research will also investigate whether the addition of 131I-Omburtamab lowers the chance of tumor growth and improves survival compared to patients in the past who only received chemotherapy and/or radiation therapy.

(via: PBTC-058 Patient and Family Summary_v2_05-28-2021.pdf)

Inclusion Criteria

Inclusion Criteria Group 1:

  • Patients must have a confirmed diagnosis of medulloblastoma that has come back, progressed or not responded to other standard treatment
  • Patients must be 21 years old or younger to participate 
  • Patients must be willing to undergo a surgical procedure to place an appropriate intraventricular access device (e.g., programmable ventriculoperitoneal [VP] shunt or reservoir) if they do not have one already
  • Patients must be able to be up and about for over half of their waking hours
  • Organ function and blood work requirements must be met
  • Patients must not be pregnant or get pregnant during the course of this study or for at least 6 months after. If patients are of childbearing or child fathering potential, they must be willing to use a medically acceptable form of birth control, including abstinence. 
  • Patients receiving corticosteroids at a stable or decreasing dose for at least 7 days prior to enrollment are eligible
  • Patients must be willing to agree with study visit requirements and be able to understand and sign a written informed consent document 

Inclusion Criteria Group 2: 

  • Patients must have a confirmed diagnosis of ependymoma that has come back, progressed or not responded to other standard treatment
  • Patients must have evidence of tumor reactivity for B7H3 (CD276), if prior testing is not available, patient samples must be sent to Memorial Sloan Kettering Cancer Center to be tested
  • Patients must be 21 years old or younger to participate
  • Patients must be willing to agree with study visit requirements and be able to understand and sign a written informed consent document 
  • Patients screened for this trial should be expected to meet criteria for treatment as outlined in the protocol. 

Other inclusion criteria may apply and will be discussed with you by the study team.  

PED-CITN-01 - 3CI Study: Childhood Cancer Combination Immunotherapy.

Completed

PED-CITN-01 - 3CI Study: Childhood Cancer Combination Immunotherapy.

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DiagnosisLymphoma, brain tumours except diffuse intrinsic pontine glioma, solid tumoursStudy StatusCompleted
PhaseI
AgeChild, Adult - (1 to 25 Years) RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment Administrationintravenous
Last Posted Update2024-04-10
ClinicalTrials.gov #NCT04500548
International Sponsor
National Cancer Institute (NCI)
Principal Investigators for Canadian Sites
The Hospital for Sick Children – Dr. Daniel Morgenstern


Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

Testing the Combination of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) in Children, Adolescent, and Young Adult Patients With Relapsed/Refractory Cancers That Have an Increased Number of Genetic Changes, The 3CI Study

This study investigates the side effects of the combination of two immunotherapy medications called nivolumab and ipilimumab, and to see how well they work in treating children, adolescents and young adults with cancers that have come back (relapsed) or does not respond to treatment (refractory) and have an increased number of genetic changes. Immunotherapy with nivolumab and ipilimumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

This study is being done to help doctors learn if the combination of nivolumab and ipilimumab can help children, adolescents, and young adults patients live longer.

This study will have two parts

  • PART I: A tissue sample from the tumour is analysed for "tumour mutation burden" level. Patients with elevated level may be eligible for Part II.
  • PART II: Patients receive receive treatment with nivolumab or nivolumab and ipilimumab.

 

Inclusion Criteria
  • Age from 12 months to 25 years
  • Patient with a cancer that has come back (relapsed) or does not respond to treatment (refractory)
  • All tumours can be considered except leukemia and diffuse intrinsic pontine glioma
  • The tumour will be tested (part 1). It needs to to have an increased number of genetic changes for the patient to be considered for part 2
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

BP42573 - An Open-label, Multicenter, Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RO7428731 in Participants With Glioblastoma Expressing Mutant Epidermal Growth Factor Receptor Variant III

Open

BP42573 - An Open-label, Multicenter, Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RO7428731 in Participants With Glioblastoma Expressing Mutant Epidermal Growth Factor Receptor Variant III

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DiagnosisGlioblastomaStudy StatusOpen
PhaseI
Age18 Years and olderRandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDrug: RO7428731, intravenously (IV)
Last Posted Update2024-04-09
ClinicalTrials.gov #NCT05187624
International Sponsor
Hoffmann-La Roche
Principal Investigators for Canadian Sites
Princess Margaret Cancer Centre
Centres
Medical contact
N/A
Social worker/patient navigator contact
N/A
Clinical research contact
N/A

 

 

Study Description

A clinical trial to look at how safe and tolerable the drug RO7428731 is at different doses, how the body processes it, and if there are any early signs of treatment efficacy of RO7428731 in patients with glioblastoma that has the marker EGFRvIII

Via: Clinical Trial – Glioblastoma – Safety, Tolerability, Pharm... (roche.com)

Inclusion Criteria
  • Diagnosis of glioblastoma with a tumour expression called EGFRvIII
  • Must have completed standard of care therapy prior to joining this study
  • Must be up and about at least 70% of their waking hours
  • Adequate organ functions prior to start of study treatment
  • Willingness to abide by contraceptive measures for the duration of the study.

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team

ADP 0044-002 - A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T Cells in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

Open

ADP 0044-002 - A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T Cells in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

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DiagnosisSynovial Sarcoma, Myxoid Liposarcoma, Round Cell LiposarcomaStudy StatusOpen
PhaseII
Age10 Years to 75 Years RandomisationYES
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationGenetic: afamitresgene autoleucel (previously ADP-A2M4) Single infusion of autologous genetically modified afamitresgene autoleucel (previously ADP-A2M4) Dose: 1.0 x109 to 10x109 transduced by a single intravenous infusion
Last Posted Update2024-04-09
ClinicalTrials.gov #NCT04044768
International Sponsor
Adaptimmune
Principal Investigators for Canadian Sites
Princess Margaret Cancer Centre - Dr. A. Razak
Centres
Medical contact
N/A
Social worker/patient navigator contact
N/A
Clinical research contact
N/A

 

 

Study Description

This study is to investigate how effective and safe the use of SPEAR™ T cells is in patients with Synovial Sarcoma or Myxoid/Round Cell Liposarcoma.

Inclusion Criteria
  • Age ≥16 (10 years at selected sites) and <=75 years
  • Diagnosis of advanced synovial sarcoma or myxoid liposarcoma / myxoid round cell liposarcoma with the appropriate genetic marker
  • Measurable disease
  • Adequate performance status (patient's level of functioning) 

Note: other protocol defined Inclusion criteria may apply and will be discussed with you by the study team.

Publications

A kinase-cGAS cascade to synthesize a therapeutic STING activator - PubMed (nih.gov)

CFI-400945-AML-201/TWT-202 - Phase 1b/2 Clinical Study of the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of CFI-400945 as a Single Agent or in Combination With Azacitidine in Patients With AML, MDS or CMML

Open

CFI-400945-AML-201/TWT-202 - Phase 1b/2 Clinical Study of the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of CFI-400945 as a Single Agent or in Combination With Azacitidine in Patients With AML, MDS or CMML

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DiagnosisAcute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML)Study StatusOpen
PhaseI/II
Age18 Years and older RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: CFI-400945 (oral) Arm 2A only: Azacitidine (IV)
Last Posted Update2024-04-09
ClinicalTrials.gov #NCT04730258
International Sponsor
Treadwell Therapeutics, Inc
Principal Investigators for Canadian Sites
Princess Margaret Cancer Centre
Centres
Medical contact
N/A
Social worker/patient navigator contact
N/A
Clinical research contact
N/A

 

 

Study Description

The purpose of this study is to test the safety of an investigational drug called CFI-400945 alone and in combination with azacitidine.

Inclusion Criteria
  • Patients must be >18 years of age
  • Patients must have a qualifying diagnosis of Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) that has come back or not responded to other treatment
  • Have acceptable laboratory screening results within certain limits
  • Be able to carry out light daily work with little/no restriction

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team

IGNYTE-ESO - Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, Alone or in Combination With Other Agents, in HLA-A2+ Participants With NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO)

Closed to enrollment

IGNYTE-ESO - Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, Alone or in Combination With Other Agents, in HLA-A2+ Participants With NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO)

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DiagnosisAdvanced tumorsStudy StatusClosed to enrollment
PhaseII
Age10 Years and olderRandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDrug: Letetresgene autoleucel (lete-cel, GSK3377794) letetresgene autoleucel will be administered. Drug: Fludarabine Fludarabine will be used as the lymphodepleting chemotherapy Drug: Cyclophosphamide Cyclophosphamide will be used as the lymphodepleting chemotherapy.
Last Posted Update2024-04-09
ClinicalTrials.gov #NCT03967223
International Sponsor
GlaxoSmithKline
Principal Investigators for Canadian Sites
Maisonneuve-Rosemont Hospital
Centres
Medical contact
N/A
Social worker/patient navigator contact
N/A
Clinical research contact
N/A

 

 

Study Description

This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumours.

Inclusion Criteria
  • Participant must be greater than or equal to 10 years of age on the day of signing informed consent.
  • Participant has a diagnosis of synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS)
  • Participant should be up and about 60% of their waking hours with minimal to no restrictions 
  • Participant must meet the lab and organ function requirements prior to starting study

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team